Radiation Safety - Drug Handling

Handle POSLUMA with safety measures to minimize radiation exposure [see Warnings and Precautions ( 5.2)] . Use waterproof gloves, effective radiation shielding, including syringe shields, and other appropriate safety measures when handling and administering POSLUMA.

Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides.

Recommended Dose and Administration Instructions

Patient Preparation

Instruct patients to drink water prior to administration of POSLUMA to ensure adequate hydration and to continue drinking and voiding frequently for the first few hours following administration to reduce radiation exposure.

Image Acquisition

• Patients should void immediately prior to imaging.
• Position the patient supine with arms above the head.
• Begin image acquisition approximately 60 minutes after POSLUMA injection.
• Image acquisition should start from mid-thigh and proceed to the base of the skull.
• Scan duration is approximately 20 minutes depending on the number of bed positions and acquisition time per bed position (typically 3 minutes). Adapt imaging technique according to the equipment used and patient characteristics in order to obtain the best image quality possible.

Image Display and Interpretation

POSLUMA binds to PSMA. PET images obtained using POSLUMA indicate the presence of PSMA in tissues [see Clinical Pharmacology ( 12.1)] . Lesions should be considered suspicious if uptake is greater than physiologic uptake in that tissue or greater than adjacent background if no physiologic uptake is expected. Tumors that do not express PSMA will not be visualized. Increased uptake in tumors is not specific for prostate cancer [see Warnings and Precautions ( 5.1)].

Radiation Dosimetry

Estimated absorbed radiation doses for adult patients following intravenous injection of POSLUMA are shown in Table 1. The effective radiation dose resulting from the administration of the recommended activity of 296 MBq of POSLUMA is 4.1 mSv. The radiation absorbed doses to the critical organs of adrenal glands, kidneys, and submandibular glands for the recommended activity of 296 MBq are 54.3 mGy, 51 mGy, and 43.8 mGy, respectively. When PET/CT is performed, exposure to radiation will increase by an amount dependent on the settings used in the CT acquisition.